Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000022460
Ethics application status
Approved
Date submitted
3/11/1994
Date registered
3/11/1994
Date last updated
11/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
IBCSG VI - Adjuvant therapy in node positive pre/perimenopausal breast cancer patients: CMF 3 vs. 6 with or without reintroduction of chemotherapy.
Scientific title
Adjuvant therapy in node positive pre/perimenopausal breast cancer patients: CMF 3 vs. 6 with or without reintroduction of chemotherapy.
Secondary ID [1] 3 0
National Clinical Trials Registry: NCTR90
Universal Trial Number (UTN)
Trial acronym
IBCSG VI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 6 0
Condition category
Condition code
Cancer 6 6 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm A: Adjuvant CMF (cyclophosphamide 100mg/m^2 orally daily days 1-14; methotrexate 40mg/m^2 iv days 1 and 8; 5-fluorouracil 600mg/m^2 iv days 1 and 8)x 6 monthly cycles (duration of each cycle = 28 days)

Arm B: Adjuvant CMF (cyclophosphamide 100mg/m^2 orally daily days 1-14; methotrexate 40mg/m^2 iv days 1 and 8; 5-fluorouracil 600mg/m^2 iv days 1 and 8) x 6 monthly cycles (duration of cycle = 28 days) + 3 single reinduction cycles (duration of cycle = 28 days) of CMF (cyclophosphamide 100mg/m^2 orally daily days 1-14; methotrexate 40mg/m^2 iv days 1 and 8; 5-fluorouracil 600mg/m^2 iv days 1 and 8) at 9, 12 and 15 months

Arm C: Adjuvant CMF (cyclophosphamide 100mg/m^2 orally daily days 1-14; methotrexate 40mg/m^2 iv days 1 and 8; 5-fluorouracil 600mg/m^2 iv days 1 and 8) x 3 monthly cycles (duration of cycle = 28 days)

Arm D: Adjuvant CMF (cyclophosphamide 100mg/m^2 orally daily days 1-14; methotrexate 40mg/m^2 iv days 1 and 8; 5-fluorouracil 600mg/m^2 iv days 1 and 8) x 3 monthly cycles (duration of cycle = 28 days) + 3 single reinduction cycles (duration of cycle = 28 days) of CMF (cyclophosphamide 100mg/m^2 orally daily days 1-14; methotrexate 40mg/m^2 iv days 1 and 8; 5-fluorouracil 600mg/m^2 iv days 1 and 8) at 6, 9 and 12 months
Intervention code [1] 1245 0
Treatment: Drugs
Comparator / control treatment
See above "Description of Intervention". Please note that this study closed to recruitment in 1993.
Control group
Active

Outcomes
Primary outcome [1] 7 0
Disease-free survival
Timepoint [1] 7 0
All patients will be assessed by clinicians for recurrence of disease every third month during the first 2 years, every six months for years 3-5 and annually thereafter for life.
Secondary outcome [1] 8 0
Overall survival
Timepoint [1] 8 0
All patients will be assessed by clinicians for the secondary endpoints every third month during the first 2 years, every six months for years 3-5 and annually thereafter for life. Treatment related side effects will also be assessed after every CMF (cyclophosphamide, methotrexate, 5-fluorouracil) administration.
Secondary outcome [2] 9 0
Sites of relapse
Timepoint [2] 9 0
All patients will be assessed by clinicians for the secondary endpoints every third month during the first 2 years, every six months for years 3-5 and annually thereafter for life. Treatment related side effects will also be assessed after every CMF (cyclophosphamide, methotrexate, 5-fluorouracil) administration.
Secondary outcome [3] 10 0
Treatment-related side-effects
Timepoint [3] 10 0
All patients will be assessed by clinicians for the secondary endpoints every third month during the first 2 years, every six months for years 3-5 and annually thereafter for life. Treatment related side effects will also be assessed after every CMF (cyclophosphamide, methotrexate, 5-fluorouracil) administration.

Eligibility
Key inclusion criteria
a) >52 years, and LNMP (last normal menstrual period) within 1 year OR b) <=52 years, and LNMP within 3 years, or currently menstruating OR c) <=55 years, and hysterectomy without bilateral oophorectomy OR d) Biochemical confirmation of continuing ovarian function (in questionable cases); All N+ patients with ER status determined for stratification; Tumour confined to breast with or without metastatic spread limited to ipsilateral axilla; Axillary nodes were not fixed and there was no arm oedema; WBC is >= 4,000/mm^3 and platelet count is >= 100,000/mm^3; Documented evidence of adequate renal ( creatinine < 120umol/L) and hepatic (bilirubin < 20umol/L, SGOT < 60 iu/L) function; Patients must give consent to be in study and be geographically accessible for follow-up; UICC performance status of 0 – 2; Either total mastectomy, quadrantectomy or lumpectomy with axillary clearance, performed no earlier than 6 weeks (addendum 2, previously 4 weeks) before randomization; A minimum of 8 lymph nodes has been histologically examined
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Malignant breast tumours other than carcinoma; Inflammatory carcinoma, with ulceration or infiltration of skin, or peau d'orange; T3b ot T4 breast carcinoma, or N2 or N3 nodal status; Bilateral malignancies, or mass in opposite breast; Less than total mastectomy procedures; Pregnant or lactating women; Previous or concomitant malignancy; Prior therapy for breast cancer; Clinically positive nodes in axilla opposite to affected breast; Other non-malignant systemic diseases preventing treatment options/follow-up; Psychiatric or addictive disorders preventing informed consent; Premenopausal patients with ER+ primary tumours; Bone scintigrams showing hot spots which cannot be confirmed as benign disease; N- patients (Addendum 1)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central Randomisation by Telephone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer Generated Stratified Blocks
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/1986
Actual
15/08/1986
Date of last participant enrolment
Anticipated
Actual
1/04/1993
Date of last data collection
Anticipated
Actual
Sample size
Target
1554
Accrual to date
Final
1554
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 7 0
Self funded/Unfunded
Name [1] 7 0
Australia and New Zealand Breast Cancer Trials Group
Country [1] 7 0
Australia
Primary sponsor type
Other Collaborative groups
Name
International Breast Cancer Study Group
Address
Effingerstrasse 40, 3008 Bern
Country
Switzerland
Secondary sponsor category [1] 6 0
Other Collaborative groups
Name [1] 6 0
Austraia and New Zealand Breast Cancer Trials Group
Address [1] 6 0
PO BOX 155
HRMC NSW 2310
Country [1] 6 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 24 0
Newcastle Mater Misericordiae Hospital
Ethics committee address [1] 24 0
Ethics committee country [1] 24 0
Australia
Date submitted for ethics approval [1] 24 0
Approval date [1] 24 0
Ethics approval number [1] 24 0
Ethics committee name [2] 25 0
Sydney
Ethics committee address [2] 25 0
Ethics committee country [2] 25 0
Australia
Date submitted for ethics approval [2] 25 0
Approval date [2] 25 0
Ethics approval number [2] 25 0
Ethics committee name [3] 26 0
Adelaide
Ethics committee address [3] 26 0
Ethics committee country [3] 26 0
Australia
Date submitted for ethics approval [3] 26 0
Approval date [3] 26 0
Ethics approval number [3] 26 0
Ethics committee name [4] 27 0
Melbourne
Ethics committee address [4] 27 0
Ethics committee country [4] 27 0
Australia
Date submitted for ethics approval [4] 27 0
Approval date [4] 27 0
Ethics approval number [4] 27 0
Ethics committee name [5] 28 0
Perth
Ethics committee address [5] 28 0
Ethics committee country [5] 28 0
Australia
Date submitted for ethics approval [5] 28 0
Approval date [5] 28 0
Ethics approval number [5] 28 0
Ethics committee name [6] 29 0
Auckland Hospital
Ethics committee address [6] 29 0
Ethics committee country [6] 29 0
New Zealand
Date submitted for ethics approval [6] 29 0
Approval date [6] 29 0
Ethics approval number [6] 29 0
Ethics committee name [7] 293843 0
Peter MacCallum Cancer Centre
Ethics committee address [7] 293843 0
Ethics committee country [7] 293843 0
Australia
Date submitted for ethics approval [7] 293843 0
01/06/1986
Approval date [7] 293843 0
01/07/1986
Ethics approval number [7] 293843 0
IBCSG VI

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35513 0
Prof John F Forbes
Address 35513 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 35513 0
Australia
Phone 35513 0
+61 2 4985 0113
Fax 35513 0
Email 35513 0
[email protected]
Contact person for public queries
Name 10434 0
Corinna Beckmore
Address 10434 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 10434 0
Australia
Phone 10434 0
+61 2 4925 3068
Fax 10434 0
+61 2 49850141
Email 10434 0
[email protected]
Contact person for scientific queries
Name 1362 0
John F Forbes
Address 1362 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 1362 0
Australia
Phone 1362 0
+61 2 4985 0113
Fax 1362 0
+ 61 2 4960 1539
Email 1362 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.